Central Venous CathetersNCT05109338
Efficacy of Ben-Guard Garment in Reducing Pediatric Central Line Complications
A study testing Ben-Guard Garment in people with Central Venous Catheters, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
Central venous catheter (CVC) insertion is a common surgical procedure performed in children for the delivery of nutritional support, medications, frequent blood draws or transfusions. Read more about this study
- Who is it for?
- Ages 0 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Central Venous Catheters
- What is being tested?
- Ben-Guard Garment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 5 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participants age 0-10
- medical disease or condition that requires a CVC for treatment, supportive care or nutritional support
- English Speaking
Who cannot join
- Any patient who received a non-tunneled CVC
- Any patient who had a tunneled CVC placed from an outside institution
- Age > 10
- Patients that cannot communicate or read English
Trial locations and contacts
1 site in 1 country.
United States1 site
American Family Children's Hospital
Madison, Wisconsin, 53792
About this study
Official title: Efficacy of Ben-Guard Garment in Reducing the Frequency of Pediatric Central Line Complications: A Pilot Study
Central venous catheter (CVC) insertion is a common surgical procedure performed in children for the delivery of nutritional support, medications, frequent blood draws or transfusions. Maintaining hygienic conditions is absolutely necessary in order to avoid contamination of the catheter and tubing to avoid bloodstream infections. Fractures in the tubing is a common complication that places children at increased risk for infections. In order to help keep the tubing stable to avoid fractures and dislodgements, a wearable device was created called Ben-Guard. This pilot study is being undertaken to determine if the Ben-Guard device will reduce the incidence and severity of adverse events in children requiring CVCs.
Read the detailed description
Conduct a pragmatic pilot study of the Ben-Guard Catheter Safety Device in 40 pediatric patients with central venous catheters (CVC). Participants will be issued 3-5 garments, which are expected to be worn at all times. This study will be conducted over an 18 month period. Participants are expected to wear the garment daily for the duration of the study (or duration of their treatment if <18 months). Data will be reviewed every 3 months to measure the garment's acceptability and effect on the frequency of central line-associated complications. Outcomes will be compared to a matched retrospective cohort. This study will use the device consistent with the description as a registered FDA Class 1 device. The investigators are conducting this study to clinically and scientifically evaluate the device's ability to change the frequency of CVC fractures and CVC complications in children.
- Conditions
- Central Venous Catheters
- Being tested
- Ben-Guard Garment
- Keywords
- Central venous catheter, complication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ben-Guard GarmentDevice
Wearable device designed to secure CVCs and gastrointestinal feeding tubes. The Ben-Guard Catheter Securement Device was designed specifically to better secure and conceal CVC tubing, protecting the patient by keeping tubing closer to the body.
| Study group | Role | What they receive |
|---|---|---|
| Ben-Guard user | Experimental | Participants will wear the garment for up to 18 months while needing a central line catheter. Receives: Device: Ben-Guard Garment |
| Retrospective match control | No intervention | Matched historical control for intervention group based on age, gender and duration of use of a central venous catheter. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Number of CVC Fractures
compared to retrospective cohort
Measured: Up to 18 months
Secondary outcomes (4)
Mean Number of CVC Dislodgements
The frequency of CVC dislodgements compared to a matched retrospective cohort.
Measured: Up to 18 months
Total Number of Central-Line Associated Blood Stream Infections (CLABSIs)
Number of central-line associated blood stream infections compared to a matched retrospective cohort.
Measured: Up to 18 months
Total Number of CVC-related Emergency Department or Urgent Care Visits
The number of CVC-related emergency department visits compared to a matched retrospective cohort.
Measured: Up to 18 months
Mean CVC-related Total Healthcare Associated Costs
Mean CVC-related total healthcare-associated costs compared to a matched retrospective cohort.
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start1 Oct 2021
- Primary completion5 Apr 2024
- Study completion5 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Venous CathetersStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Nichol, MD, PhD, Principal investigator, UW School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109338
- Sponsor's protocol ID
- 2021-0781
- Other IDs
- Protocol Version 8/3/2021, A539790, fund for garments
- Status last verified
- May 2024
- First submitted
- 26 Oct 2021
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ben-Guard Garment in Reducing the Frequency of Pediatric Central Line Complications: A Pilot Study
- ClinicalTrials.gov ID
- NCT05109338
- Acronym / sponsor ID
- 2021-0781
- Conditions
- Central Venous Catheters
- Keywords
- Central venous catheter, complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 5 Apr 2024 (actual)
- Study completion
- 5 Apr 2024 (actual)
- First posted
- 5 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Central venous catheter (CVC) insertion is a common surgical procedure performed in children for the delivery of nutritional support, medications, frequent blood draws or transfusions. Maintaining hygienic conditions is absolutely necessary in order to avoid contamination of the catheter and tubing to avoid bloodstream infections. Fractures in the tubing is a common complication that places children at increased risk for infections. In order to help keep the tubing stable to avoid fractures and dislodgements, a wearable device was created called Ben-Guard. This pilot study is being undertaken to determine if the Ben-Guard device will reduce the incidence and severity of adverse events in children requiring CVCs.
Detailed description
Conduct a pragmatic pilot study of the Ben-Guard Catheter Safety Device in 40 pediatric patients with central venous catheters (CVC). Participants will be issued 3-5 garments, which are expected to be worn at all times. This study will be conducted over an 18 month period. Participants are expected to wear the garment daily for the duration of the study (or duration of their treatment if <18 months). Data will be reviewed every 3 months to measure the garment's acceptability and effect on the frequency of central line-associated complications. Outcomes will be compared to a matched retrospective cohort. This study will use the device consistent with the description as a registered FDA Class 1 device. The investigators are conducting this study to clinically and scientifically evaluate the device's ability to change the frequency of CVC fractures and CVC complications in children.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ben-Guard user | Experimental | Device: Ben-Guard GarmentParticipants will wear the garment for up to 18 months while needing a central line catheter. |
| Retrospective match control | No intervention | –Matched historical control for intervention group based on age, gender and duration of use of a central venous catheter. |
Who may qualify
- Ages
- 0 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Participants age 0-10
- medical disease or condition that requires a CVC for treatment, supportive care or nutritional support
- English Speaking
Key exclusion criteria (4 listed)
- Any patient who received a non-tunneled CVC
- Any patient who had a tunneled CVC placed from an outside institution
- Age > 10
- Patients that cannot communicate or read English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ben-Guard GarmentWearable device designed to secure CVCs and gastrointestinal feeding tubes. The Ben-Guard Catheter Securement Device was designed specifically to better secure and conceal CVC tubing, protecting the patient by keeping tubing closer to the body. | Device | Ben-Guard user |
Primary outcome
Mean Number of CVC Fractures
Time frame: Up to 18 months
compared to retrospective cohort
4 secondary outcomes
Mean Number of CVC Dislodgements
Time frame: Up to 18 months
Total Number of Central-Line Associated Blood Stream Infections (CLABSIs)
Time frame: Up to 18 months
Total Number of CVC-related Emergency Department or Urgent Care Visits
Time frame: Up to 18 months
Mean CVC-related Total Healthcare Associated Costs
Time frame: Up to 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Individual participant dataSharing planned: No
Related trials for Central Venous Catheters
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Oral Switch in Bloodstream Infections in Immunocompromised Children
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Frailty and Ultrasound-Guided Central Venous Catheterization Difficulty in Adult Cardiac Surgery Patients
Frailty, Cardiac Surgery
Enrolling by invitationObservational study
Ultrasound Guidance vs. Landmark Technique for Catheter Malposition in IJV Catheterization
Catheter Malposition, Central Venous Catheterization
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Medical Adhesive and Barrier Products for Preventing MARSI in Central Venous Catheter Dressings
Medical Adhesive Related Skin Injury, Central Venous Catheter
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Nichol, MD, PhD principal investigator
UW School of Medicine and Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ben-Guard Garment in people with Central Venous Catheters, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Number of CVC Fractures (time frame: Up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.